UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038031 |
|---|---|
| Receipt number | R000043359 |
| Scientific Title | Evaluation of muscle fatigue relieving or recovery effect of propolis-containing food. |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2021/03/11 10:31:42 |
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Basic information
Public title
Evaluation of muscle fatigue relieving or recovery effect of propolis-containing food.
Acronym
Evaluation of muscle fatigue relieving or recovery effect of propolis-containing food.
Scientific Title
Evaluation of muscle fatigue relieving or recovery effect of propolis-containing food.
Scientific Title:Acronym
Evaluation of muscle fatigue relieving or recovery effect of propolis-containing food.
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the relieving and recovery effect of propolis for muscle fatigue when the subjects take propolis for 1 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle stiffness, voluntary muscle strength, and muscle activity are measured 1 week after intake.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Propolis
Intake:787.5 mg
Ingesion:7 days
Interventions/Control_2
Propolis
Intake:100 mg
Ingesion:7 days
Interventions/Control_3
placebo
Ingesion:7 days
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy Japanese men aged greater than or equal to 18 years, less than 35 years at the time of obtaining informed consent.
2. Subjects who can walk independently and can measure physical exercise performance.
3. Subjects who do not plan to change their lifestyle habits for a test period.
Key exclusion criteria
1. Subjects who have a history of asthma or current medical history.
2. Subjects who have allergies to bee products (honey etc.), conifers, trees of Pinaceae, poplar and salicylic acid.
3. Subjects who have serious illness or medical history such as diabetes, liver disease, kidney disease, heart disease.
4. Subjects who have medical history or history of food allergies or current medical history.
5. Others who judged that the investigator is inappropriate as the subject.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Akagi |
Organization
Shibaura Institute of Technology
Division name
Systems engineering and Science
Zip code
337-8570
Address
307 Fukasaku,Minuma-ku, Saitama-shi, Saitama
TEL
048-720-6021
rakagi12@shibaura-it.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Akagi |
Organization
Shibaura Institute of Technology
Division name
Systems engineering and Science
Zip code
337-8570
Address
307 Fukasaku,Minuma-ku, Saitama-shi, Saitama
TEL
048-720-6021
Homepage URL
rakagi12@shibaura-it.ac.jp
Sponsor or person
Institute
Shibaura Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shibaura Institute of Technology Biotechnology Research Ethics Committee
Address
3-7-5 Toyosu, Koto-ku, Tokyo
Tel
03-5859-7340
tgakuji@ow.shibaura-it.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2021 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043359
